Perioperative Iron With Erythropoietin in Bilateral Total Knee Replacement Arthroplasty (TKRA) (SNUBH)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Perioperative Intravenous Iron With Erythropoietin for the Prevention of Postoperative Severe Anemia and Reduction of Transfusion in Bilateral Total Knee Replacement Arthroplasty|
- postoperative hemoglobin [ Time Frame: postoperative 1, 2, 3, 5 day and 2, 6 week ] [ Designated as safety issue: Yes ]
- serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT) [ Time Frame: preoperation and postoperation ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: group IE
The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation
Drug: iron sucrose, erythropoietin-β
The 200 mg of iron sucrose diluted with 100 ml of normal saline was given intravenously over one hour and the 3000 IU of Epo-β was injected subcutaneously.
Placebo Comparator: group C
The group C received saline as same method.
Drug: normal saline
100 ml of normal saline was given intravenously over one hour and 0.5ml was injected subcutaneously.
Other Name: sodium chloride
Total knee replacement arthroplasty (TKRA) in severe osteoarthritis usually requires extensive soft tissue and bone dissection associated with substantial bleeding. Because TKRA is performed with a pneumatic tourniquet, intraoperative bleeding is not substantial, however, over 80% of the total blood loss occurs within the first 24 hour after the operation and the hidden blood loss is 50% of the total loss, making the true blood loss twice. Consequently, many patients can become anemic at early postoperative period and this anemic condition may lead to overall physical deterioration which include fatigue, dizziness, reduced exercise tolerance and delayed recovery.
Therefore, many patients frequently received the autologous or allogenic blood transfusion. In order to reduce the allogenic blood transfusion (ABT), various methods have been used, such as preoperative autologous blood donation (PABD), use of pharmacologic agents, iron or erythropoietin (Epo) and postoperative blood salvage. All of the above methods have been proved to reduce the ABT effectively6, without increase in cost.
Iron and Epo have been used widely in a variety of clinical situations instead of allogenic RBC transfusion. They also have been used for augmenting PABD or improving preoperative hemoglobin (Hb) level. However, there still remains a controversy about the efficacy of the method on the postoperative anemia. We think that these various results may be related with individual iron state of the patients and dose of drug or timing of drug application.
In this trial, iron and Epo are planned to be administered to the iron deficient non anemic patients during the operation and once again after surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012063
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi, Korea, Republic of, 463-707|
|Principal Investigator:||Hyoseok Na, pf||Seoul National University Bundang Hospital|